Regulatory Consulting
Proven Track Record of Success
We deliver high-quality, results-driven regulatory consulting backed by deep industry expertise.
From initial strategy through to approval — clear guidance, hands-on support, and proven outcomes.
What We Do
Stay compliant. Stay approved.
Regulatory Compliance
We guide you through every aspect of Malaysia’s Medical Device Act 2012 and its regulations — ensuring your product meets all MDA requirements from classification to post-market surveillance.
What’s included
- Medical device classification (Class A, B, C, D)
- MDA registration and renewal management
- Conformity assessment and technical file review
- Post-market surveillance planning
- Regulatory gap analysis and remediation
- Labelling and Instructions for Use (IFU) review
Your mandatory local presence in Malaysia.
Local Authorised Representative (LAR)
Manufacturers located outside Malaysia must appoint a Local Authorised Representative (LAR) to sell in Malaysia — a mandatory requirement under Act 737 and the Medical Device Regulations 2012. Innosafe can act as your LAR, register your devices with MDA, hold your product licences, and ensure ongoing compliance with local laws and regulations.
What’s included
- Act as your official LAR with the Medical Device Authority (MDA)
- MDA product registration and licence holding on your behalf
- Serve as your primary contact point with MDA
- Keep importers and distributors updated on registration certificates
- Post-market surveillance and regulatory intelligence updates
- Adverse event and incident reporting to competent authorities
- Field safety corrective actions and product recall liaison
- Complaints handling and safety notification management
Good Distribution Practice, done right.
GDPMD Audit & Compliance
Good Distribution Practice for Medical Devices (GDPMD) is a mandatory requirement for licensed importers and distributors in Malaysia. We conduct internal audits to assess your readiness, liaise directly with auditors on your behalf, and develop a customised GDPMD Quality Management System tailored to your company’s operations — ensuring full compliance with MDA’s distribution standards.
What’s included
- Customised GDPMD Quality Management System (QMS) for your company
- Internal GDPMD audit against MDA requirements
- Gap analysis and corrective action planning
- Liaison with GDPMD auditors on your behalf
- Audit preparation and documentation review
- Standard Operating Procedure (SOP) development
- Staff training and awareness support
- Post-audit follow-up and close-out assistance
Expert Regulatory Consulting Services
Discover how our expertise guides medical device manufacturers through seamless regulatory approvals in Malaysia.
Regulatory Strategy Development
We tailor strategic plans to navigate Malaysia’s medical device regulations with precision and confidence.
Compliance Documentation Support
Our team crafts and reviews all necessary documentation to meet regulatory standards efficiently.
Market Entry Assistance
We provide hands-on support to ensure your medical devices are market-ready and fully compliant.
Ongoing Regulatory Updates
Stay ahead with our monitoring services that keep you informed of evolving Malaysian regulations.
Our Approach
Discover our proven methodology that guides medical device manufacturers through seamless regulatory approval in Malaysia.
Step One: Regulatory Assessment
We begin by thoroughly evaluating your product’s compliance requirements to establish a clear pathway for approval.
Step Two: Documentation & Submission
Our experts prepare and submit all necessary regulatory documents, ensuring accuracy and adherence to local standards.
Step Three: Market Entry Support
We provide ongoing guidance and support post-approval to help you successfully launch and maintain compliance in Malaysia.
Begin Your Journey to Market Compliance Today
Partner with Innosafe Healthcare Solutions to navigate Malaysia’s regulatory landscape confidently. Gain expert insights, streamline approvals, and accelerate your product launch with our tailored consulting services.